New blood thinner may lower chances of clots in high-risk heart patients: FDA

May 21, 2012
New blood thinner may lower chances of clots in high-Risk heart patients: FDA
Agency's advisory panel to vote on whether Xarelto should be approved for treating acute coronary syndrome.

(HealthDay) -- The new blood thinner Xarelto appears to lower the chances of potentially fatal blood clots in high-risk heart patients, a U.S. Food and Drug Administration review has found.

The review came in briefing documents that were filed Monday in advance of an FDA advisory panel meeting Wednesday, at which the panel is to vote on whether to recommend approval of Xarelto for treating people with (a group of conditions brought on by sudden reduced blood flow to the heart).

The FDA is not required to follow the advice of its expert panels, but the agency typically does. A final decision is expected by the end of June, according to the documents.

Xarelto (rivaroxaban) is one of a new class of that have been developed to overcome some of the problems that exist with the standard treatment, (Coumadin), which requires constant dose monitoring. Warfarin's effectiveness also can be altered by certain foods and other medications. Xarelto already is approved for use by those with atrial fibrillation () and by people who are having hip- or knee-replacement surgery.

In the FDA briefing documents, an agency reviewer recommended approving the drug for treatment of acute coronary syndrome, mostly because trial data showed there was a reduction in , even though there was also an increased risk of potentially fatal bleeding.

"However, what is not reflected in the sponsor's analysis are minor bleeding events," FDA reviewer Dr. Karen Hicks wrote in the briefing documents. "While it is true that these bleeding events typically do not lead to death or irreversible harm, these events may represent the biggest problem for both patients and if rivaroxaban is approved."

"While reductions in [cardiovascular] death still trump these bleeding events, if rivaroxaban is approved, we should expect a number of bleeding events that will require medical attention," Hicks wrote. "Carefully selecting patients for rivaroxaban therapy will be necessary to mitigate these bleeding risks."

In research presented at the American Stroke Association's International Stroke Conference in New Orleans last February, Australian doctors followed more than 14,000 people who took either Xarelto or warfarin for a median of two years. Of those patients, 136 had bleeding in the brain.

People who took Xarelto -- and suffered from the most common type of atrial fibrillation and didn't have heart valve damage -- were about one-third less likely to experience bleeding in the brain than those who took warfarin, the investigators found.

Explore further: J&J wins US approval for new blood thinner

More information: The U.S. National Institute of Neurological Disorders and Stroke has more about stroke.

Related Stories

J&J wins US approval for new blood thinner

July 2, 2011
(AP) -- Johnson & Johnson said Friday that U.S. regulators have approved its new type of blood thinner shown to reduce deadly blood clots in patients who have undergone knee and hip replacements.

Bayer drug unproven as stroke preventer: US

September 6, 2011
US regulators said Tuesday that Xarelto, a Bayer-made drug approved in July for preventing blood clots, is so far unproven for a new proposed use as a stroke preventer.

Rivaroxaban has less risk of brain bleeding in patients at high risk for stroke

February 2, 2012
For patients with a type of irregular heart beat called atrial fibrillation (AF), a new anti-clotting drug might be better at preventing clot-related strokes while minimizing the risk of causing a bleeding stroke. The research ...

Stroke risk high when anti-clotting drugs stopped

April 25, 2012
Some patients with irregular heartbeats who are taken off anti-clotting medication face a high risk of stroke or blood clotting within a month, according to new research presented at the American Heart Association's Emerging ...

Easy-to-use blood thinners likely to replace Coumadin

February 6, 2012
Within a few years, a new generation of easy-to-use blood-thinning drugs will likely replace Coumadin for patients with irregular heartbeats who are at risk for stroke, according to a journal article by Loyola University ...

Study shows ability of new agent to prevent strokes in patients with atrial fibrillation

August 10, 2011
In the primary result from the largest double-blind study ever completed to assess a drug's effect in the prevention of stroke in patients with atrial fibrillation, a common heart rhythm abnormality, rivaroxaban, an anti-clotting ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.